pharmaphorum

JANUARY 27, 2023

Then, at the end of the study, [making sure] that all of the study documentation, [the] study report, matches up with everything that has happened during the study. Having the ability of these groups to be able to communicate directly with patients is tremendous.” It really enables the smooth running of studies.”

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 111

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Macheras, and K.

Documentation 52

Documentation FDA Communication Packaging 52

Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. HRSA published the proposed 340B "mega-guidance" the following year but ultimately withdrew it in 2017.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

SEPTEMBER 22, 2023

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. It’s worth considering how you can do so, such as through building trust and open communication. A long history of medical racism in the U.S. Sources: How legacy of medical racism shapes U.S. health care today.

Insurance Coverage 52

Insurance Coverage Communication Documentation Compounding 52

Hospital Pharmacy Europe

JANUARY 19, 2023

In 2016, the country’s first National Strategic Plan in Antimicrobial Resistance 2017–2021 was published. Accompanying leaflets for patients have been developed and also digital versions of the documentation. was a remarkably effective way to establish good communication, he said. By 2021, reductions of 15.2%

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 percent as EU average with some Member States as high as 25 percent).

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

PQA

JUNE 27, 2024

Background: PQA’s Efforts to Standardize TAT In 2017 and in collaboration with NASP, PQA identified and prioritized specialty pharmacy measure concepts for development. For example, one participant described how varying levels of “urgency” could be communicated to pharmacists, empowering them to prioritize prescriptions for expedited review.

Specialty Pharmacies 40

Specialty Pharmacies Communication Packaging Documentation 40

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. The second edition of the ISPE guide received regulatory input from the FDA and other agencies and was published in 2017. Published 2017. 5 European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Procedia CIRP 60 (2017): 86–91. initiatives.

Packaging 52

Packaging Documentation Communication Data Entry 52

The Checkup by Singlecare

OCTOBER 30, 2023

Carefully read these documents as they contain important safety information, including information about interactions. Additionally, communicate with your providers about any side effects you’re experiencing, even if you aren’t sure if they are related to escitalopram. In some cases, side effects may be related to a drug interaction.

Communication 52

Communication Documentation Dosage 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Published 19 January 2017. You may unsubscribe from these ISPE communications at any time.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 2 (2017): 44–46. link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 You may unsubscribe from these ISPE communications at any time. October 2004.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MARCH 15, 2023

7 December 2017. 1 December 2017. There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. [link] 4 World Economic Forum. “3 7 November 2022.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

MARCH 7, 2023

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” EMA/CHMP/QWP/545525/2017 Rev. Committee for Medicinal Products for Human Use. 27 January 2022.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

IDStewardship

APRIL 13, 2023

09.01.01), which went live in January of 2017. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. ” Given that we cannot be everywhere all the time, how can this be demonstrated?

Hospitals 246

Hospitals Documentation Communication Patient Care 246

The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

Communication 64

Communication FDA Labelling Documentation 64

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients? MDCG 2019-11.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients? MDCG 2019-11.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! Nov 20, 2017. Physiol Rev.

Health and Personal Care Stores 111

Health and Personal Care Stores Immunization Documentation Compounding 111

ISPE

JULY 5, 2023

Due to the expanding workload of the ETP, CDER has begun implementing ETP program enhancements to improve strategy and operation and to enhance communication with those adopting new technologies. September 2017. Eventually all CM technologies will graduate from the ETP. Guidance for Industry. link] 8 Allison, G., Garcia, T.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 10, 2023

PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?” 5 (2017):421–27. en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf 9 European Commission. Edwards, K.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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Documentation FDA Hospitals Dosage 97

The Thyroid Pharmacist

JANUARY 20, 2023

In one small study published in 2017 in the Journal of Complementary Medicine , after eight weeks of treatment, ashwagandha was found to improve serum TSH, T3 and T4 levels, normalizing serum levels. [14] doi:10.1155/2017/9217567; Cohen MM. Published 2017 Dec 1. doi:10.1155/2017/8024857 [48] Lee Y, Jung JC, Jang S, et al.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Immunization Compounding Documentation 98

Pharmaceutical Technology

JUNE 22, 2023

According to the document, this scheme would instead harm patient access to drugs, which will take longer to turn generic. The EU previously focused on AMR through the One Health Action Plan, which was released in 2017. The voucher system marks another one of the EU’s steps against the rising threat of AMR announced in recent years.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

APRIL 16, 2023

mL autoinjector debuted in 2017. To learn more, download the document below. The NIT thus simplifies the injection process by eliminating the need for patients to attach the needle to the cartridge, making for a simplified and safe end-user experience – and freeing autoinjectors to carry larger doses than existing PFS-based devices.

Documentation 52

Documentation Communication Hospitals 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Documentation 98

Documentation Dosage FDA Communication 98

The Checkup by Singlecare

FEBRUARY 19, 2025

When nerve cells are damaged, communication between the brain and body is affected, and symptoms like numbness, tingling, or pain may develop. Magnesium supplementation can significantly lower blood pressure in people with noncommunicable chronic diseases, according to a 2017 meta-analysis. But what does the research say?

Documentation 105

Documentation Compounding Communication 105

PQA

NOVEMBER 26, 2024

In documentation of the care provided, the MTP Categories Framework promotes consistent identification of MTPs found and the interventions taken to resolve MTPs within MTM services. It is clear to me that this rational approach is vital for practice standardization and documentation. Updated August 2017. Third ed.

Patient Care 52

Patient Care Documentation Communication 52